Selumetinib for Cancer

Recruiting at115 trial locations

Overseen by Carl E Allen

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II Pediatric MATCH trial studies how well selumetinib sulfate works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway activation mutations that have spread to other places in the body and have come back or do not respond to treatment. Selumetinib sulfate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Research Team

Carl E Allen

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for patients with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have MAPK pathway mutations and are not responding to treatment. Participants must be able to swallow capsules, have a body surface area >= 0.5 m^2, and meet specific health criteria including organ function and blood counts. Pregnant women or those on certain medications cannot join.

Inclusion Criteria

I have recovered from side effects of my previous cancer treatments.

My stem cell treatment followed the required time guidelines.

My cancer has a specific BRAF V600 mutation.

Exclusion Criteria

Pregnant or breast-feeding women

I am currently taking other medications.

I do not have any infections that are currently uncontrolled.

Treatment Details

Interventions

• Selumetinib Sulfate (MAPK/ERK Kinase Inhibitor)

Trial Overview The study tests Selumetinib Sulfate's effectiveness in treating relapsed or refractory cancers with MAPK mutations. It's a phase II trial aiming to see if this drug can halt cancer cell growth by inhibiting necessary enzymes.

Participant Groups

Group I: Treatment (selumetinib) Experimental Treatment 3 Interventions

Patients receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School